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Week 96 efficacy of lopinavir/ritonavir monotherapy in virologically suppressed patients with HIV: a randomized non-inferiority trial (ANRS 140 DREAM)

dc.rights.licenseopenen_US
dc.contributor.authorMEYNARD, J. L.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMOINOT, Laetitia
dc.contributor.authorLANDMAN, R.
dc.contributor.authorMORAND-JOUBERT, L.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBESSEGHIR, Amel
dc.contributor.authorKOLTA, S.
dc.contributor.authorSPIRE, B.
dc.contributor.authorTODESCO, E.
dc.contributor.authorBOUCHAUD, O.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorFAGARD, Catherine
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorCHENE, Geneviève
dc.contributor.authorGIRARD, P. M.
dc.date.accessioned2020-12-08T08:31:08Z
dc.date.available2020-12-08T08:31:08Z
dc.date.issued2018-06-01
dc.identifier.issn1460-2091 (Electronic) 0305-7453 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/21342
dc.description.abstractEnBackground: Sparing of antiretroviral drug classes could reduce the toxicity and cost of maintenance treatment for HIV infection. Objectives: To evaluate the non-inferiority of efficacy and the safety of lopinavir/ritonavir (r) monotherapy versus a single-tablet regimen of efavirenz, emtricitabine and tenofovir (EFV/FTC/TDF) over 2 years. Methods: Adults on stable ART with plasma HIV-1 RNA viral load <50 copies/mL for the past 12 months and no documented treatment failure were randomized to receive either lopinavir/r or EFV/FTC/TDF for 2 years. The primary endpoint was the proportion of patients without treatment failure at week 96 (viral load <50 copies/mL at week 96, confirmed at week 98), without study treatment discontinuation, a new AIDS-defining illness, or death. Results: In the ITT analysis, the primary endpoint was reached by, respectively, 64% and 71% of patients in the lopinavir/r (n = 98) and EFV/FTC/TDF arms (n = 97), yielding a difference of -6.8% (lower limit of the 95% two-sided CI: -19.9%). Sanger and UltraDeep sequencing showed the occurrence of PI mutations in the lopinavir/r arm (n = 4) and of NNRTI and/or NRTI mutations in the EFV/FTC/TDF arm (n = 2). No unexpected serious clinical events occurred. Conclusions: Lopinavir/r monotherapy cannot be considered non-inferior to EFV/FTC/TDF. PI resistance rarely emerged in the lopinavir/r arm and did not undermine future PI options. Two years of lopinavir/r monotherapy had no deleterious clinical impact when compared with EFV/FTC/TDF.
dc.language.isoENen_US
dc.subject.enMORPH3Eus
dc.subject.enCIC1401
dc.title.enWeek 96 efficacy of lopinavir/ritonavir monotherapy in virologically suppressed patients with HIV: a randomized non-inferiority trial (ANRS 140 DREAM)
dc.title.alternativeJ Antimicrob Chemotheren_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1093/jac/dky055en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed29584910en_US
bordeaux.journalThe Journal of antimicrobial chemotherapyen_US
bordeaux.page1672-1676en_US
bordeaux.volume73en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue6en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamMORPH3Eusen_US
bordeaux.teamCIC1401en_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.exportfalse
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